PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy

The Multi-center, Open-label,Randomized Comparison Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02805153

Enrollment

215

Registered

2016-06-17

Start date

2013-04-30

Completion date

2016-02-29

Last updated

2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

PEG-rhG-CSF

Brief summary

The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy

Interventions

DRUGPEG-rhG-CSF

DRUGrhG-CSF

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients with age between 18 and 70 years * diagnosis of breast cancer patients * chemotherapy naive * Karnofsky Performance Status ≥ 70 * Written informed consent are acquired

Exclusion criteria

* uncontrolled infection * Have accepted radiotherapy within 4 weeks before anticipated the study * pregnancy * Other situations that investigators consider as contra-indication for this study

Design outcomes

Primary

Measure	Time frame
the occurrence rate of grade IV neutropenia during the first chemotherapy cycle	through first cycle of chemotherapy,an average of 1 month

Secondary

Measure	Time frame
the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)	through the next three consecutive cycles chemotherapy,an average of 3 months
the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)	through the next three consecutive cycles chemotherapy,an average of 3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026